FELBAMATE PACKAGE INSERT PDF
See package insert. How to take and store Felbamate? Follow your doctor’s directions. Call if you have any questions. Usually, your doctor will tell you to start by. Felbatol is the brand name used in the United States for felbamate. Read the black box warning in the Package Insert to your patient and obtain any necessary . Felbamate, also known as Felbatol, has been approved by the Food and Drug about all potential risks before using this drug and read the package insert.
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Monitor concentrations of normethsuximide in patients treated with methsuximide and felbamate. Therefore, use of praziquantel with felbamate, a CYP3A4 inducer, should be done with caution as concomitant use may produce therapeutically ineffective concentrations of praziquantel. Amphetamines may decrease the seizure threshold and may increase the risk of seizures. Anticonvulsants that stimulate the activity of this enzyme include: Adequate dosages of anticonvulsants should be continued when a phenothiazine is added.
Adverse effects, such as sedation, lethargy, ataxia, or insomnia may be potentiated. Patients receiving anticonvulsants had approximately twice the risk of suicidal behavior or ideation 0. The use of felbamate is associated with a marked increase in the incidence of aplastic anemia pancytopenia in packaage presence of a bone marrow largely depleted of hematologic precursor cells.
Felbatol (felbamate) dose, indications, adverse effects, interactions from
To minimize potential for interactions, consider administering oral anticonvulsants such as felbamate at least 1 hour before or at least 4 hours after colesevelam. Loperamide is metabolized by the hepatic enzyme CYP3A4; felbamate is a mild inducer of this enzyme.
Serum concentrations of other anticonvulsants should be obtained and dosage adjustments made as necessary. Monitoring should include baseline liver function tests i. Too little is felbamatd about felbamate-induced aplastic anemia to determine fatality percentages or which patients are more at risk for this serious adverse reaction. Clinically significant interactions have been reported when doxorubicin was coadministered with inhibitors of CYP3A4, resulting in increased concentration and clinical effect of doxorubicin.
Higher lidocaine doses may felbamatd required; titrate to effect. Belladonna Packahe Ergotamine; Phenobarbital: Theoretically, CY2C19 inhibitors, such as felbamate, could increase carisoprodol plasma levels, with potential for enhanced CNS depressant effects. For storage information, see specific product information within the How Supplied section. Moderate Concomitant use of systemic lidocaine and felbamate may decrease lidocaine plasma concentrations. Additionally, patients taking non-oral combination contraceptives or estrogens or progestins for hormone replacement therapy may also experience reduced clinical efficacy; dosage adjustments may be necessary.
Telbamate effect of felbamate on labor and delivery in humans is unknown. Consider the benefits of breast-feeding, the felbamatw of potential drug exposure, and the risk of an untreated or inadequately treated condition.
Moderate Caution is warranted with the coadministration of hydroxychloroquine and antiepileptic drugs, such as felbamate. If these drugs are used together, monitor for escitalopram-associated adverse reactions.
The manufacturer advises to avoid use of felbamate in patients with pre-existing hepatic disease. Kava Kava, Piper methysticum: Bone marrow stem cell changes may occur weeks to months earlier than clinical presentation.
Use clopidogrel and felbamate together felamate caution and monitor for reduced efficacy of clopidogrel. Previously untreated patients should be titrated under close clinical supervision. If these drugs are administered concurrently, monitor the patient for signs of lack of efficacy of rivaroxaban.
Any patient withdrawn from the drug for liver injury are considered at increased risk for such problems if the drug is re-introduced.
We do not record any personal information entered above. The need for indefinite continuation in treating any condition should be based on confirmation of the condition and its potential cause s. The exact mechanism by which felbamate exerts its anticonvulsant activity is unknown.
Minor Bone marrow suppression is associated with guanidine therapy. Felbamate causes a decrease in the steady-state plasma concentration of carbamazepine but increases concentrations of carbamazepine epoxide, a carbamazepine metabolite.
Whether pre-existing hepatic disease increases the risk of felbamate-induced hepatotoxicity is unknown. Induction of CYP3A4 by felbamate may significantly reduce the plasma concentrations of simeprevir, resulting in treatment failure. While the OH-clarithromycin active metabolite concentrations felbamatte increased, this metabolite has different antimicrobial activity compared to clarithromycin.
Felbamate is a mild inducer of the hepatic isoenzyme CYP3A4; ritonavir is metabolized by this enzyme. The effect of food on GI absorption from the oral suspension has not been evaluated.
Major Estrogens and progestins are both susceptible to drug interactions with hepatic enzyme inducing drugs. Felbamate is contraindicated in patients with current or previous hepatic disease or dysfunction e.
Hepatic disease, hepatitis, hepatotoxicity, jaundice. Monitoring of the anticonvulsant serum concentration is recommended. High or toxic serum concentrations should become a consideration for dosage adjustments.
Major Avoid concurrent use of felbamate with bedaquiline. Decreased serum concentrations of vorapaxar and thus decreased efficacy are possible when vorapaxar, a CYP3A4 substrate, is coadministered with felbamate, a mild CYP3A inducer.
Moderate Caution is advised when administering terbinafine with felbamate.
Monitor patients on anticonvulsants carefully when a TCA is used concurrently. Minor Use caution if coadministration of maraviroc with felbamate is necessary, due to a possible decrease in maraviroc exposure. In Septemberthe manufacturer issued a flbamate stating 8 cases of acute hepatic failure, including 4 deaths, were associated with the use of felbamate.
Because of the serious toxicities associated with the drug, including aplastic anemia and hepatic failure, breast-feeding should generally be avoided during treatment with felbamate. Clinical signs and symptoms may include infection, bleeding, or anemia.